Significant variation in histopathological assessment of endoscopic resections for Barrett's neoplasia suggests need for consensus reporting: propositions for improvement.

Endoscopic resection (ER) is an important diagnostic step in management of patients with early Barrett's esophagus (BE) neoplasia. Based on ER specimens, an accurate histological diagnosis can be made, which guides further treatment. Based on depth of tumor invasion, differentiation grade, lymphovascular invasion, and margin status, the risk of lymph node metastases and local recurrence is judged to be low enough to justify endoscopic management, or high enough to warrant invasive surgical esophagectomy. Adequate assessment of these histological risk factors is therefore of the utmost importance. Aim of this study was to assess pathologist concordance on these histological features on ER specimens and evaluate causes of discrepancy. Of 62 challenging ER cases, one representative H&E slide and matching desmin and endothelial marker were digitalized and independently assessed by 13 dedicated GI pathologists from 8 Dutch BE expert centers, using an online assessment module. For each histological feature, concordance and discordance were calculated. Clinically relevant discordances were observed for all criteria. Grouping depth of invasion categories according to expanded endoscopic treatment criteria (T1a and T1sm1 vs. T1sm2/3), ≥1 pathologist was discrepant in 21% of cases, increasing to 45% when grouping diagnoses according to the traditional T1a versus T1b classification. For differentiation grade, lymphovascular invasion, and margin status, discordances were substantial with 27%, 42%, and 32% of cases having ≥1 discrepant pathologist, respectively. In conclusion, histological assessment of ER specimens of early BE cancer by dedicated GI pathologists shows significant discordances for all relevant histological features. We present propositions to improve definitions of diagnostic criteria.

Prognostic implications of resting distal coronary-to-aortic pressure ratio compared with fractional flow reserve: a 10-year follow-up study after deferral of revascularisation.

INTRODUCTION: The distal coronary-to-aortic pressure ratio (Pd/Pa) is a non-hyperaemic physiological index to assess the functional severity of coronary stenoses. Studies comparing Pd/Pa with fractional flow reserve (FFR) show superior diagnostic efficiency for myocardial ischaemia. Nevertheless, a direct comparison regarding long-term clinical outcomes is still not available. The present observational study compared the prognostic value of Pd/Pa and FFR for major adverse cardiac events (MACE) during a 10-year follow-up period after deferral of revascularisation. METHODS: Between April 1997 and September 2006, we evaluated 154 coronary stenoses (154 patients) in which revascularisation was deferred with intracoronary pressure and flow measurements during the resting and hyperaemic state. Long-term follow-up (median: 11.8 years) was performed to document the occurrence of MACE, defined as a composite of cardiac death, myocardial infarction and target vessel revascularisation. RESULTS: The study population comprised angiographically intermediate coronary stenoses, with a mean diameter stenosis of 53 ± 8%, and intermediate physiological severity with a median FFR of 0.82 (Q1, Q3: 0.76, 0.88). The association of Pd/Pa with long-term MACE was similar to that of FFR [FFR-standardised hazard ratio (sHR): 0.77, 95% confidence interval (CI): 0.61-0.98; Pd/Pa-sHR: 0.80, 95% CI: 0.67-0.96]. In the presence of disagreement between Pd/Pa and FFR, normal Pd/Pa was generally associated with high coronary flow reserve (CFR) and a favourable clinical outcome, whereas abnormal Pd/Pa was generally associated with CFR around the ischaemic cut-point and an impaired clinical outcome, regardless of the accompanying FFR value. CONCLUSION: The present study suggests that Pd/Pa provides at least equivalent prognostic value compared with FFR. When Pd/Pa disagreed with FFR, the baseline index conferred superior prognostic value in this study population.

Adherence to pre-set benchmark quality criteria to qualify as expert assessor of dysplasia in Barrett's esophagus biopsies - towards digital review of Barrett's esophagus.

Background: Dysplasia assessment of Barrett's esophagus biopsies is associated with low observer agreement; guidelines advise expert review. We have developed a web-based review panel for dysplastic Barrett's esophagus biopsies. Objective: The purpose of this study was to test if 10 gastrointestinal pathologists working at Dutch Barrett's esophagus expert centres met pre-set benchmark scores for quality criteria. Methods: Ten gastrointestinal pathologists twice assessed 60 digitalized Barrett's esophagus cases, enriched for dysplasia; then randomised (7520 assessments). We tested predefined benchmark quality criteria: (a) percentage of 'indefinite for dysplasia' diagnoses, benchmark score ≤14% for all cases, ≤16% for dysplastic subset, (b) intra-observer agreement; benchmark score ≥0.66/≥0.39, (c) percentage agreement with 'gold standard diagnosis'; benchmark score ≥82%/≥73%, (d) proportion of cases with high-grade dysplasia underdiagnosed as non-dysplastic Barrett's esophagus; benchmark score ≤1/78 (≤1.28%) assessments for dysplastic subset. Results: Gastrointestinal pathologists had seven years' Barrett's esophagus-experience, handling seven Barrett's esophagus-cases weekly. Three met stringent benchmark scores; all cases and dysplastic subset, three met extended benchmark scores. Four pathologists lacked one quality criterion to meet benchmark scores. Conclusion: Predefined benchmark scores for expert assessment of Barrett's esophagus dysplasia biopsies are stringent and met by some gastrointestinal pathologists. The majority of assessors however, only showed limited deviation from benchmark scores. We expect further training with group discussions will lead to adherence of all participating gastrointestinal pathologists to quality criteria, and therefore eligible to join the review panel.

Short versus conventional hydration for prevention of kidney injury during pre-TAVI computed tomography angiography.

BACKGROUND: Computed tomography angiography (CTA) is required in the work-up for transcatheter aortic valve implantation (TAVI). However, CTA may cause contrast-induced acute kidney injury (CI-AKI). We hypothesised that a short (1 h, 3 ml/kg/h sodium bicarbonate) hydration protocol is not inferior to conventional (24 h, 1 ml/kg/h saline) hydration in avoiding a decline in renal function in patients with impaired renal function. METHODS AND RESULTS: Single-centre randomised non-inferiority trial in patients with impaired renal function who underwent pre-TAVI CTA. Patients were randomised on a 1:1 ratio to short hydration (SHORT; 1 h sodium bicarbonate, 3 ml/kg/h) or conventional hydration (CONV; 24 h saline, 1 ml/kg/h). Outcomes included percentage change in serum creatinine until 2-6 days after CTA with a non-inferiority margin of 10% and an increase on the Borg dyspnoea scale ≥1 point. Seventy-four patients were included. Increase in creatinine was 6 µmol/l (95% CI 2.5-9.3) in the SHORT versus 2 µmol/l (95% CI-1.4 to 6.3) in the CONV arm (p = 0.167). The percentage change was 4.6% (95% CI 2.0-7.3%) in the SHORT arm versus 2.5% (95% CI: 0.8 to 5.8%) in the CONV arm. The difference in percentage increase in creatinine between the two arms was 2.1% (95% CI: 2.0-6.2%; p-value non-inferiority: <0.001). CI-AKI and a need for dialysis were not observed. An increase of ≥1 point on the Borg scale (dyspnoea scale ranging from 1 (lowest) to 10 (highest)) was seen in 1 patient in the SHORT arm versus 5 patients in the CONV arm (2.9% vs 16.1%, p = 0.091). CONCLUSION: For patients with impaired renal function undergoing pre-TAVI CTA, a short 1­h, low-volume hydration protocol with sodium bicarbonate is not inferior to conventional 24-h, high-volume saline hydration.

Development of benchmark quality criteria for assessing whole-endoscopy Barrett's esophagus biopsy cases.

BACKGROUND: Dysplasia in Barrett's esophagus (BE) biopsies is associated with low observer agreement among general pathologists. Therefore, expert review is advised. We are developing a web-based, national expert review panel for histological review of BE biopsies. OBJECTIVE: The aim of this study was to create benchmark quality criteria for future members. METHODS: Five expert BE pathologists, with 10-30 years of BE experience, weekly handling 5-10 cases (25% dysplastic), assessed a case set of 60 digitalized cases, enriched for dysplasia. Each case contained all slides from one endoscopy (non-dysplastic BE (NDBE), n = 21; low-grade dysplasia (LGD), n = 20; high-grade dysplasia (HGD), n = 19). All cases were randomized and assessed twice followed by group discussions to create a consensus diagnosis. Outcome measures: percentage of 'indefinite for dysplasia' (IND) diagnoses, intra-observer agreement, and agreement with the consensus 'gold standard' diagnosis. RESULTS: Mean percentage of IND diagnoses was 8% (3-14%) and mean intra-observer agreement was 0.84 (0.66-1.02). Mean agreement with the consensus diagnosis was 90% (95% prediction interval (PI) 82-98%). CONCLUSION: Expert pathology review of BE requires the scoring of a limited number of IND cases, consistency of assessment and a high agreement with a consensus gold standard diagnosis. These benchmark quality criteria will be used to assess the performance of other pathologists joining our panel.

Trends in patient characteristics and clinical outcome over 8 years of transcatheter aortic valve implantation.

AIM: In the evolving field of transcatheter aortic valve implantations (TAVI) we aimed to gain insight into trends in patient and procedural characteristics as well as clinical outcome over an 8­year period in a real-world TAVI population. METHODS: We performed a single-centre retrospective analysis of 1,011 consecutive patients in a prospectively acquired database. We divided the cohort into tertiles of 337 patients; first interval: January 2009-March 2013, second interval: March 2013-March 2015, third interval: March 2015-October 2016. RESULTS: Over time, a clear shift in patient selection was noticeable towards lower surgical risks including Society of Thoracic Surgeons predicted risk of mortality score and comorbidity. The frequency of transfemoral TAVI increased (from 66.5 to 77.4%, p = 0.0015). Device success improved (from 62.0 to 91.5%, p < 0.0001) as did the frequency of symptomatic relief (≥1 New York Heart Association class difference) (from 73.8 to 87.1%, p = 0.00025). Complication rates decreased, including in-hospital stroke (from 5.0 to 2.1%, p = 0.033) and pacemaker implantations (from 10.1 to 5.9%, p = 0.033). Thirty-day mortality decreased (from 11.0 to 2.4%, p < 0.0001); after adjustment for patient characteristics, a mortality-risk reduction of 72% was observed (adjusted hazard ratio [HR]: 0.28, 95% confidence interval [CI]: 0.13-0.62). One-year mortality rates decreased (from 23.4 to 11.4%), but this was no longer significant after a landmark point was set at 30 days (mortality from 31 days until 1 year) (adjusted HR: 0.69, 95% CI: 0.41-1.16, p = 0.16). CONCLUSION: A clear shift towards a lower-risk TAVI population and improved clinical outcome was observed over an 8­year period. Survival after TAVI improved impressively, mainly as a consequence of decreased 30-day mortality.

Five-year clinical follow-up of the STENTYS self-apposing stent in complex coronary anatomy: a single-centre experience with report of specific angiographic indications.

OBJECTIVES: We sought to investigate angiographic indications for the use of the STENTYS technique and evaluated the long-term safety and clinical efficacy of the stent. BACKGROUND: Coronary lesions involving complex anatomy, including aneurysmatic, ectatic, or tapered vessel segments often carry a substantial risk of stent malapposition. The self-apposing stent technique may reduce the risk of stent malapposition and therefore improve clinical outcomes. METHODS: A total of 120 consecutive patients treated with the STENTYS stent were included (drug-eluting stent (DES) n = 101, bare-metal stent (BMS) n = 19). All lesions were scored for angiographic indications for the STENTYS stent, including aneurysms, ectasias, tapering, absolute diameters, bifurcation lesions, and saphenous vein grafts. Off-line quantitative coronary angiography analyses were performed pre-procedure and post-procedure. Five years follow-up was obtained including cardiac death, target vessel myocardial infarction (TV-MI), target vessel revascularisation, stent thrombosis, and the composite endpoint target vessel failure (cardiac death, TV-MI and target vessel revascularisation). RESULTS: Angiographic indications for STENTYS use were aneurysm (30%), ectasia (19%), tapering (27%), bifurcation lesions (8%), and saphenous vein graft lesions (16%) and absolute diameters (22%). Mean maximal diameter was 4.51 ± 0.99 mm. At 5­year follow-up target vessel failure rates were 24.1% in the total cohort (DES 22.8% vs. BMS 33%, p = 0.26). Definite stent thrombosis rate was 3.8% at 5­year follow-up in this cohort with complex and high-risk lesions (DES 4.5% vs. BMS 0%, p = 0.39). CONCLUSIONS: Angiographic indications for the use of the self-apposing stent were complex lesions with atypical coronary anatomy. Our data showed reasonable stent thrombosis rates at 5­year follow-up, considering the high-risk lesion characteristics.

Digital microscopy as valid alternative to conventional microscopy for histological evaluation of Barrett's esophagus biopsies.

Management of Barrett's esophagus (BE) relies heavily on histopathological assessment of biopsies, associated with significant intra- and interobserver variability. Guidelines recommend biopsy review by an expert in case of dysplasia. Conventional review of biopsies, however, is impractical and does not allow for teleconferencing or annotations. An expert digital review platform might overcome these limitations. We compared diagnostic agreement of digital and conventional microscopy for diagnosing BE ± dysplasia. Sixty BE biopsy glass slides (non-dysplastic BE (NDBE); n = 25, low-grade dysplasia (LGD); n = 20; high-grade dysplasia (HGD); n = 15) were scanned at ×20 magnification. The slides were assessed four times by five expert BE pathologists, all practicing histopathologists (range: 5-30 years), in 2 alternating rounds of digital and conventional microscopy, each in randomized order and sequence of slides. Intraobserver and pairwise interobserver agreement were calculated, using custom weighted Cohen's kappa, adjusted for the maximum possible kappa scores. Split into three categories (NDBE, IND, LGD+HGD), the mean intraobserver agreement was 0.75 and 0.84 for digital and conventional assessment, respectively (p = 0.35). Mean pairwise interobserver agreement was 0.80 for digital and 0.85 for conventional microscopy (p = 0.17). In 47/60 (78%) of digital microscopy reviews a majority vote of ≥3 pathologists was reached before consensus meeting. After group discussion, a majority vote was achieved in all cases (60/60). Diagnostic agreement of digital microscopy is comparable to that of conventional microscopy. These outcomes justify the use of digital slides in a nationwide, web-based BE revision platform in the Netherlands. This will overcome the practical issues associated with conventional histologic review by multiple pathologists.

Mid-term and long-term safety and efficacy of bioresorbable vascular scaffolds versus metallic everolimus-eluting stents in coronary artery disease: A weighted meta-analysis of seven randomised controlled trials including 5577 patients.

AIMS: Mid- and long-term safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) have been studied in randomised trials; however, most were not individually powered for clinical endpoints. We performed a weighted meta-analysis comparing mid- and long-term outcomes in patients treated with the BVS compared with the Xience metallic stent. METHODS AND RESULTS: Randomised trials comparing the BVS and Xience were identified by searching MEDLINE, EMBASE and conference abstracts. Seven trials were included (BVS n = 3258, Xience n = 2319) with follow-up between 1-3 years. The primary outcome of target lesion failure occurred more frequently in BVS compared with Xience [OR 1.34; 95% CI 1.11-1.62, p = 0.003]. Overall definite or probable device thrombosis occurred more frequently with the BVS [OR 2.86; 95% CI 1.88-4.36, p < 0.001] and this extended beyond 1 year of follow-up [OR 4.13; 95% CI 1.99-8.57, p < 0.001]. Clinically indicated or ischaemia driven target lesion revascularisation [OR 1.43; 95% CI 1.11-1.83, p = 0.005] and myocardial infarction (all MI) [OR 1.64; 95% CI 1.20-2.23, p = 0.002] were more frequently seen in the BVS compared with Xience. Rates of target vessel failure [OR 1.15; 95% CI 0.91-1.46, p = 0.25] and cardiac death [OR 0.91; 95% CI 0.57-1.46, p = 0.71] were not significantly different between BVS and Xience. CONCLUSION: This meta-analysis shows a higher rate of target lesion failure and an almost threefold higher rate of device thrombosis in BVS compared with Xience, which extends beyond the first year. Device thrombosis did not lead to an overall increased (cardiac) mortality.

Long-term outcomes and cost effectiveness of high-dose dexamethasone for cardiac surgery: a randomised trial.

Prophylactic intra-operative administration of dexamethasone may improve short-term clinical outcomes in cardiac surgical patients. The purpose of this study was to evaluate long-term clinical outcomes and cost effectiveness of dexamethasone versus placebo. Patients included in the multicentre, randomised, double-blind, placebo-controlled DExamethasone for Cardiac Surgery (DECS) trial were followed up for 12 months after their cardiac surgical procedure. In the DECS trial, patients received a single intra-operative dose of dexamethasone 1 mg.kg-1 (n = 2239) or placebo (n = 2255). The effects on the incidence of major postoperative events were evaluated. Also, overall costs for the 12-month postoperative period, and cost effectiveness, were compared between groups. Of 4494 randomised patients, 4457 patients (99%) were followed up until 12 months after surgery. There was no difference in the incidence of major postoperative events, the relative risk (95%CI) being 0.86 (0.72-1.03); p = 0.1. Treatment with dexamethasone reduced costs per patient by £921 [€1084] (95%CI £-1672 to -137; p = 0.02), mainly through reduction of postoperative respiratory failure and duration of postoperative hospital stay. The probability of dexamethasone being cost effective compared with placebo was 97% at a threshold value of £17,000 [€20,000] per quality-adjusted life year. We conclude that intra-operative high-dose dexamethasone did not have an effect on major adverse events at 12 months after cardiac surgery, but was associated with a reduction in costs. Routine dexamethasone administration is expected to be cost effective at commonly accepted threshold levels for cost effectiveness.

Practice of ST-segment elevation myocardial infarction care in the Netherlands during four snapshot weeks with the National Cardiovascular Database Registry for Acute Coronary Syndrome.

BACKGROUND: Clinical registries provide information on the process of care and patient outcomes, with the potential to improve the quality of patient care. A large Dutch national acute coronary syndrome (ACS) registry is currently lacking. Recently, we initiated the National Cardiovascular Database Registry (NCDR) for ACS in the Netherlands. The purpose of this study was to assess the NCDR ACS registry on feasibility and data completeness during a pilot phase of four snapshot weeks. METHODS: Between 2013 and 2015, we invited all hospitals in the Netherlands to record a predefined dataset for every patient that was admitted to their hospital with ST-segment elevation myocardial infarction (STEMI). Data were entered in an online case report form. All patient-specific data were encrypted to ensure privacy. RESULTS: A total of 392 patients were registered in 35 centres. The mean age of the patients was 64 years (SD 13); 8% of patients presented with signs of cardiogenic shock and 11% with an out-of-hospital cardiac arrest. The median time from first medical contact to percutaneous coronary intervention (PCI) was 75 min (IQR 51-108) and this was significantly longer for patients who presented at a non-PCI centre or to a primary care physician. In-hospital and 30-day mortality rates were 5.2% and 7.8%, respectively. The amount of completeness varied, with improved completeness over time. CONCLUSION: This report shows that a Dutch ACS registry is feasible with respect to STEMI patients. Data completeness, however, was suboptimal. Improved data completeness is warranted for the future.

Pre-hospital management, procedural performance and outcomes for primary percutaneous coronary intervention in ST-elevation myocardial infarction in the Netherlands: Insights from the Dutch cohort of the APPOSITION-III trial.

AIM: The aim of this study was to achieve useful insights into pre-hospital management and procedural performance for ST-elevation myocardial infarction (STEMI) in the Netherlands by extrapolating patient characteristics, and procedural and clinical outcomes of the Dutch patient cohort from the APPOSITION-III trial. METHODS: This is a retrospective analysis from the APPOSITION-III trial with respect to the geographical borders of STEMI management. The APPOSITION-III trial was a European registry for the use of the STENTYS self-expandable stent in STEMI patients undergoing primary percutaneous coronary intervention (PPCI). 965 Patients were enrolled mainly in the Netherlands (n = 420, 43.5 % of the overall study population), Germany (n = 165) and France (n = 131). The data from the Dutch cohort were compared with both the overall study population, and the French and German cohorts, respectively, as well as the European Society of Cardiology (ESC) STEMI guidelines. RESULTS: In this trial there was a wide inter-country variation on symptom-to-balloon time, 165 minutes (120-318) in the Netherlands, 270 minutes (180-650) in Germany and 360 minutes (120-480) in France, respectively. In general, a preload of dual antiplatelet therapy (DAPT) combined with heparin was more often performed in the Dutch and French cohort than in the German cohort. DAPT at discharge was high across the whole APPOSITION-III population. No important differences were seen between the different groups according to the endpoints major adverse cardiac event and stent thrombosis. CONCLUSION: In the Dutch cohort of an European multicentre STEMI study (APPOSITION-III trial), the performance in terms of symptom-to-balloon time, and pre-, peri- and post-procedural medical treatment is in line with the recommendations of ESC STEMI guidelines.

Impact of percutaneous coronary intervention timing on 5-year outcome in patients with non-ST-segment elevation acute coronary syndromes. The 'wait a day' approach might be safer.

BACKGROUND: The OPTIMA trial was a randomised multicentre trial exploring the influence of the timing of percutaneous coronary intervention (PCI) on patient outcomes in an intermediate to high risk non-ST-elevation acute coronary syndrome (NSTE-ACS) population. In order to decide the best treatment strategy for patients presenting with NSTE-ACS, long-term outcomes are essential. METHODS: Five-year follow-up data from 133 of the 142 patients could be retrieved (94 %). The primary endpoint was a composite of death and spontaneous myocardial infarction (MI). Spontaneous MI was defined as MI occurring more than 30 days after randomisation. Secondary endpoints were the individual outcomes of death, spontaneous MI or re-PCI. RESULTS: No significant difference with respect to the primary endpoint was observed (17.8 vs. 10.1 %; HR 1.55, 95 % CI: 0.73-4.22, p = 0.21). There was no significant difference in mortality rate. However, spontaneous MI was significantly more common in the group receiving immediate PCI (11.0 vs. 1.4 %; HR 4.46, 95 % CI: 1.21-16.50, p = 0.02). We did not find a significant difference between the groups with respect to re-PCI rate. CONCLUSION: There was no difference in the composite of death and spontaneous MI. The trial suggests an increased long-term risk of spontaneous MI for patients treated with immediate PCI.

Nurses' perspectives on nurse-coordinated prevention programmes in secondary prevention of cardiovascular disease: a pilot survey.

BACKGROUND: Secondary prevention of coronary artery disease (CAD) is increasingly provided by nurse-coordinated prevention programs (NCPP). Little is known about nurses' perspectives on these programs. AIM: To investigate nurses' perspectives/experiences in NCPPs in acute coronary syndrome patients. METHODS: Thirteen nurses from NCPPs in 11 medical centers in the RESPONSE trial completed an online survey containing 45 items evaluating 3 outcome categories: (1) conducting NCPP visits; (2) effects of NCPP interventions on risk profiles and (3) process of care. RESULTS: Nurses felt confident in counseling/motivating patients to reduce CAD risk. Interventions targeting LDL, blood pressure and medication adherence were reported as successful, corresponding with significant improvements of these risk factors. Improving weight, smoking and physical activity was reported as less effective. Screening for anxiety/depression was suggested as an improvement. CONCLUSIONS: Nurses acknowledge the importance and effectiveness of NCPPs, and correctly identify which components of the program are the most successful. Our study provides a basis for implementation and quality improvement for NCCPs.

Peri-procedural use of rivaroxaban in elective percutaneous coronary intervention to treat stable coronary artery disease. The X-PLORER trial.

Patients on rivaroxaban requiring percutaneous coronary intervention (PCI) represent a clinical conundrum. We aimed to investigate whether rivaroxaban, with or without an additional bolus of unfractionated heparin (UFH), effectively inhibits coagulation activation during PCI. Stable patients (n=108) undergoing elective PCI and on stable dual antiplatelet therapy were randomised (2:2:2:1) to a short treatment course of rivaroxaban 10 mg (n=30), rivaroxaban 20 mg (n=32), rivaroxaban 10 mg plus UFH (n=30) or standard peri-procedural UFH (n=16). Blood samples for markers of thrombin generation and coagulation activation were drawn prior to and at 0, 0.5, 2, 6-8 and 48 hours (h) after start of PCI. In patients treated with rivaroxaban (10 or 20 mg) and patients treated with rivaroxaban plus heparin, the levels of prothrombin fragment 1 + 2 at 2 h post-PCI were 0.16 [0.1] nmol/l (median) [interquartile range, IQR] and 0.17 [0.2] nmol/l, respectively. Thrombin-antithrombin complex values at 2 h post-PCI were 3.90 [6.8]µg/l and 3.90 [10.1] µg/l, respectively, remaining below the upper reference limit (URL) after PCI and stenting. This was comparable to the control group of UFH treatment alone. However, median values for thrombin-antithrombin complex passed above the URL with increasing tendency, starting at 2 h post-PCI in the UFH-alone arm but not in rivaroxaban-treated patients. In this exploratory trial, rivaroxaban effectively suppressed coagulation activation after elective PCI and stenting.

Systematic review of perioperative selective decontamination of the digestive tract in elective gastrointestinal surgery.

BACKGROUND: Studies on selective decontamination of the digestive tract (SDD) in elective gastrointestinal surgery have shown decreased rates of postoperative infection and anastomotic leakage. However, the prophylactic use of perioperative SDD in elective gastrointestinal surgery is not generally accepted. METHODS: A systematic review of randomized clinical trials (RCTs) was conducted to compare the effect of perioperative SDD with systemic antibiotics (SDD group) with systemic antibiotic prophylaxis alone (control group), using MEDLINE, Embase and the Cochrane Central Register of Controlled Trials. Endpoints included postoperative infection, anastomotic leakage, and in-hospital or 30-day mortality. RESULTS: Eight RCTs published between 1988 and 2011, with a total of 1668 patients (828 in the SDD group and 840 in the control group), were included in the meta-analysis. The total number of patients with infection (reported in 5 trials) was 77 (19.2 per cent) of 401 in the SDD group, compared with 118 (28.2 per cent) of 418 in the control group (odds ratio 0.58, 95 per cent confidence interval 0.42 to 0.82; P = 0.002). The incidence of anastomotic leakage was significantly lower in the SDD group: 19 (3.3 per cent) of 582 patients versus 44 (7.4 per cent) of 595 patients in the control group (odds ratio 0.42, 0.24 to 0.73; P = 0.002). CONCLUSION: This systematic review and meta-analysis suggests that a combination of perioperative SDD and perioperative intravenous antibiotics in elective gastrointestinal surgery reduces the rate of postoperative infection including anastomotic leakage compared with use of intravenous antibiotics alone.

Mechanical circulatory support with the Impella 5.0 device for postcardiotomy cardiogenic shock: a three-center experience.

AIM: Postcardiotomy cardiogenic shock (PCCS) is associated with high mortality rates, despite full conventional treatment. Although the results of treatment with surgically implantable ventricular assist devices have been encouraging, the invasiveness of this treatment limits its applicability. Several less invasive devices have been developed, including the Impella system. The objective of this study was to describe our three-center experience with the Impella 5.0 device in the setting of PCCS. METHODS: From January 2004 through December 2010, a total of 46 patients were diagnosed with treatment-refractory PCCS and treated with the Impella 5.0 percutaneous left ventricular assist device at three european heart centers. Baseline and follow-up characteristics were collected retrospectively and entered into a dedicated database. RESULTS: Within the study cohort of 46 patients, mean logistic and additive EuroSCORES were 24 ± 19 and 10 ± 4. The majority of patients underwent coronary artery bypass grafting (48%) or combined surgery (33%). Half of all patients had been treated with an intra-aortic balloon pump before 5.0-implantation, 1 patient had been treated with an Impella 2.5 device. All patients were on mechanical ventilation and intravenous inotropes. The Kaplan-Meier estimate of overall 30-day survival was 39.5%. CONCLUSION: Thirty-day survival rates for patients with PCCS, refractory to aggressive conventional treatment and treated with the Impella 5.0 device, are comparable to those reported in studies evaluating surgically implantable VADs, whereas the Impella system is much less invasive. Therefore, mechanical circulatory support with the Impella 5.0 device is a suitable treatment modality for patients with severe PCCS.

Routine versus aggressive upstream rhythm control for prevention of early atrial fibrillation in heart failure: background, aims and design of the RACE 3 study.

BACKGROUND: Rhythm control for atrial fibrillation (AF) is cumbersome because of its progressive nature caused by structural remodelling. Upstream therapy refers to therapeutic interventions aiming to modify the atrial substrate, leading to prevention of AF. OBJECTIVE: The Routine versus Aggressive upstream rhythm Control for prevention of Early AF in heart failure (RACE 3) study hypothesises that aggressive upstream rhythm control increases persistence of sinus rhythm compared with conventional rhythm control in patients with early AF and mild-to-moderate early systolic or diastolic heart failure undergoing electrical cardioversion. DESIGN: RACE 3 is a prospective, randomised, open, multinational, multicenter trial. Upstream rhythm control consists of angiotensin converting enzyme inhibitors and/or angiotensin receptor blockers, mineralocorticoid receptor antagonists, statins, cardiac rehabilitation therapy, and intensive counselling on dietary restrictions, exercise maintenance, and drug adherence. Conventional rhythm control consists of routine rhythm control therapy without cardiac rehabilitation therapy and intensive counselling. In both arms, every effort is made to keep patients in the rhythm control strategy, and ion channel antiarrhythmic drugs or pulmonary vein ablation may be instituted if AF relapses. Total inclusion will be 250 patients. If upstream therapy proves to be effective in improving maintenance of sinus rhythm, it could become a new approach to rhythm control supporting conventional pharmacological and non-pharmacological rhythm control.

Clinical parameters associated with collateral development in patients with chronic total coronary occlusion.

OBJECTIVE: Well-developed collaterals provide survival benefit in patients with obstructive coronary artery disease (CAD). Therefore, in this study we sought to determine which clinical variables are associated with arteriogenesis. DESIGN: Clinical and laboratory variables were collected before percutaneous coronary intervention. Multivariate analysis was performed to determine which variables are associated with the collateral flow index (CFI). PATIENTS: Data from 295 chronic total occlusion (CTO) patients (Bern, Switzerland, Amsterdam, the Netherlands and Jena, Germany) were pooled. In earlier studies, patients had varying degrees of stenosis. Therefore, different stages of development of the collaterals were used. In our study, a unique group of patients with CTO was analysed. INTERVENTIONS: Instead of angiography used earlier, we used a more accurate method to determine CFI using intracoronary pressure measurements. CFI was calculated from the occlusive pressure distal of the coronary lesion, the aortic pressure and central venous pressure. RESULTS: The mean CFI was 0.39 ± 0.14. After multivariate analysis, ß blockers, hypertension and angina pectoris duration were positively associated with CFI (B: correlation coefficient ß=0.07, SE=0.03, p=0.02, B=0.040, SE=0.02, p=0.042 and B=0.001, SE=0.000, p=0.02). Furthermore also after multivariate analysis, high serum leucocytes, prior myocardial infarction and high diastolic blood pressure were negatively associated with CFI (B=-0.01, SE=0.005, p=0.03, B=-0.04, SE=0.02, p=0.03 and B=-0.002, SE=0.001, p=0.011). CONCLUSIONS: In this unique cohort, high serum leucocytes and high diastolic blood pressure are associated with poorly developed collaterals. Interestingly, the use of ß blockers is associated with well-developed collaterals, shedding new light on the potential action mode of this drug in patients with CAD.